Index of drugs

Short-term treatment of the symptoms of gastroesophageal reflux disease (eg heartburn, regurgitation of stomach contents) in adults.

1 tabl enterally contains 20 mg of Pantoprazole in the form of pantoprazole sodium semi-professional.

Proton pump inhibitor. Pantoprazole is a substituted benzimidazole, inhibits the secretion of hydrochloric acid in parietal cells due to specific blocking of H activity⁺/ K⁺-ATP-azy (the so-called proton pump). In an acidic environment, in the light of the cells of the parietal cells, it is converted into its active form and inhibits the activity of the enzyme H⁺/ K⁺-ATP-azy, or the final stage in the production of hydrochloric acid in the stomach. The effect of the drug depends on the dose and leads to inhibition of both basal secretion and stimulated secretion (regardless of the type of stimulus). In most patients, decrease in hydrochloric acid production leads to resolution of heartburn and reflux symptoms within 1 week. It reduces gastric acidity and secondarily, in a reversible manner, increases gastrin secretion to an extent proportional to the decrease in acidity. Because pantoprazole binds to a proton pump at the cellular receptor level, it can affect the secretion of hydrochloric acid independently of stimulation by other substances (acetylcholine, histamine, gastrin); the effect is the same irrespective of whether the active substance is administered orally or intravenously. After oral administration, pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after 2-2.5 h. The bioavailability is about 77%, the food does not reduce the bioavailability, it can only delay the absorption of the drug. About 98% is bound to plasma proteins. It is metabolized in the liver, excreted in about 80% by the kidneys in the form of metabolites, the remaining part is excreted in the faeces. T_0,5 pantoprazole is about 1 hour.

Hypersensitivity to the active substance or to any of the excipients. Co-administration with atazanavir.

In patients with severe hepatic impairment, liver enzymes should be monitored regularly, especially if pantoprazole is used for a long time (when increased levels of liver enzymes occur, pantoprazole should be discontinued). For combination therapy, please refer to the appropriate SmPC for both medicines. In patients with suspected or diagnosed peptic ulcer disease, as well as any disturbing symptoms (eg, significant unintentional weight loss, recurrent vomiting, dysphagia, bloody vomiting or tarry stools, anemia), the cancerous background of the disease should be excluded, as treatment with pantoprazole may alleviate the symptoms of cancer and delay its diagnosis. Further studies should be considered for patients whose disease symptoms persist despite adequate treatment. Patients who have been on treatment for a long time (especially if the treatment lasts for more than a year) should remain under regular medical supervision. Lack of treatment efficacy after 4 weeks of pantoprazole requires re-diagnosis. Treatment with pantoprazole may slightly increase the risk of gastrointestinal infections with such bacteria asSalmonella, Campylobacter andC. difficile. Pantoprazole may reduce the absorption of vitamin B₁₂ (cyanocobalamin) due to hypo or achlorhydria; this should be taken into account during long-term treatment of patients with reduced vitamin B stores₁₂ or risk factors favoring the reduction of its absorption, during long-term therapy or in case of clinical symptoms. Patients treated with pantoprazole for at least 3 months (in most cases for a year) have experienced severe hypomagnesaemia; in patients who are envisaged for long-term treatment or who are taking proton pump inhibitors concomitantly with Digoxin or hypomagnesaemic agents (eg diuretics), Magnesium determination should be considered before starting treatment with pantoprazole and periodically during treatment.Proton pump inhibitors can increase the overall risk of fractures by 10-40%; Patients at risk of osteoporosis should receive care in accordance with current clinical guidelines, and provide adequate amounts of vitamin D and calcium. The use of pantoprazole with atazanavir is not recommended (reduction of atazanavir exposure).

Do not use during pregnancy unless clearly necessary. The penetration of pantoprazole into breast milk has been found. Therefore, the decision whether to continue / stop breast-feeding or to continue / stop taking the drug should be taken taking into account the benefits for the child resulting from breastfeeding and the benefits for a woman resulting from treatment with pantoprazole.

Uncommon: sleep disturbances, headache, dizziness, diarrhea, nausea, vomiting, abdominal fullness, bloating, constipation, dry mouth, epigastric pain and discomfort, increased liver enzymes (transaminases, GGTP), rash dermal, erythema, skin eruptions, pruritus, hip bust, carpal bones, spine, weakness, fatigue, malaise. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidemias and increased lipids (triglycerides, cholesterol), changes in body weight, depression (and worsening of mental state), taste disturbances, blurred vision, blurred vision, increased bilirubin , urticaria, angioneurotic edema, joint pain, muscle pain, gynecomastia, elevated body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, pancytopenia, confusion (and mental deterioration). Frequency unknown: hyponatremia, hypomagnesaemia, hypocalcemia in combination with hypomagnesaemia, hypokalaemia, hallucinations, confusion (especially in predisposed patients, as well as worsening of these symptoms in case of their previous occurrence), parasthesia, liver cell damage, jaundice, hepatic cell failure, Stevens syndrome -Johnson, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light, muscle spasms (as a result of electrolyte disturbances), interstitial nephritis (with the possibility of developing renal failure).

Orally. Adults: the recommended dose is 20 mg once a day; in order to relieve symptoms, it may be necessary to use the medicine for the Next 2-3 days. After complete resolution of the symptoms, the treatment should be discontinued - do not use the preventive medicine. Symptom relief should be felt after around the same day the drug is used. Treatment should not last longer than 4 weeks, the patient should see a doctor if the symptoms do not improve within 2 weeks of treatment.Special groups of patients. No dosage adjustment is necessary in elderly patients or patients with renal or hepatic impairment. The safety and efficacy of the medicine in children and adolescents under 18 years have not been established.Way of giving. The tablets do not chew or chew. The drug should be taken before a meal.